BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE

    MDR report key: 3993126 · Received August 8, 2014

    Report

    Report Number
    2183613-2014-01079
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    May 8, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MEDTRONIC MILACA, INC.
    Product Code
    LWP
    PMA / PMN Number
    P820003
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS BASED SOLELY ON DEVICE ANALYSIS. NO INFORMATION TO SUGGEST A DEVICE RELATED ADVERSE EVENT OR PRODUCT PROBLEM WAS RECEIVED. IF ADDITIONAL RELEVANT INFORMATION IS RECEIVED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. PRODUCT EVENT SUMMARY: DURING ANALYSIS IT WAS DETERMINED THAT THE BATTERY DRAWER WAS BROKEN AND THAT TWO CASE SCREWS, BOTH BAIL COVERS AND THE RING COVER WERE THE WRONG PART (NOTE: EVIDENCE OF NON-COMPANY PERSONNEL HAVING DISASSEMBLED AND REASSEMBLED THE UNIT). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE EXTERNAL PULSE GENERATOR (EPG) HAD BEEN SITTING IN THE BIOMEDICAL ENGINEERING DEPARTMENT ON THE "REPAIR SHELF" FOR QUITE SOME TIME AND THE REASON WAS UNKNOWN. THEREFORE, THE REPRESENTATIVE THERE DECIDED TO SEND IT INTO US TO HAVE IT CHECKED OUT JUST TO BE SAFE BEFORE THEY USE IT AGAIN. THE EPG WILL BE RETURNED. THERE WAS NO PATIENT INVOLVEMENT. IT WAS FURTHER REPORTED THAT THE GENERATOR SUBSEQUENTLY TESTED OUT OF SPECIFICATION DURING MANUFACTURER¿S ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467538 PULSE-GENERATOR, DUAL CHAMBER, IMPLANTABLE LWP MEDTRONIC MILACA, INC. 5388

    Patients

    Seq Age Sex Outcome Treatment
    1